FDA 510(k) clearances — page 957
clearances on record, most recent first.
Clearances — page 957
95,601–95,700 of 175,890- K964722 — DELTA N95 RESPIRATOR
- K964723 — RACAL N95 RESIRATOR
- K964899 — KENDALL CURITY URETERAL CATHETER
- K964927 — STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8
- K964964 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K970021 — RUSCH SUPRAPUBIC TRAY
- K953175 — AS/3 ESTPR MODULE
- K954003 — COBE HEMODYNAMIC RECIRCULATION MONITOR
- K960534 — METALLIC SPHERICAL CMC IMPLANT
- K960659 — CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
- K961498 — RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
- K962335 — MLC FIT
- K962603 — MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
- K962708 — TITANIUM CD HORIZON SPINAL SYSTEM
- K963125 — M AND R REUSABLE ELECTRODES (MULTIPLE)
- K963139 — OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
- K963302 — TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
- K963680 — TARGET MYOGLOBIN TEST
- K963741 — LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
- K964139 — SYSMEX CA-6000
- K964401 — KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
- K964493 — OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964496 — CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC
- K964497 — CERALAS DIODE LASER SYSTEM (CERALAS D15)
- K964501 — SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964512 — CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964521 — DEPUY DUPONT PHANTOM SUTURE ANCHOR
- K964614 — ULTRAFERA WOUND DRESSING
- K964623 — TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
- K964655 — UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
- K964786 — ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
- K965007 — ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES
- K965038 — GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
- K965169 — STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
- K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
- K970176 — HCG CONTROLS
- K960037 — SUGITA AVM MICROCLIP
- K962105 — PLANNED SOPHIED CLASSIC
- K964735 — DENTINSENSE
- K965006 — AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)
- K953976 — SAFE MICRO
- K960850 — ACCESS CHLAMYDIA ASSAY
- K961024 — BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
- K961730 — RAPID GRAM-POSITIVE ID SYSTEM
- K961968 — BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
- K962653 — MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT
- K963104 — 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
- K963645 — HERPES GROUP IGG ELISA TEST SYSTEM
- K963673 — IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
- K964245 — PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
- K964419 — MIRACLE - EAR (ITE/ITC/CIC)
- K964485 — PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
- K964494 — SLEEPWIZARD
- K964575 — SYMPACATH HYDROGEL COATED FOLEY
- K964608 — MRT-35A V9.0
- K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
- K964691 — TCB TEMPORARY CROWN AND BRIDGE MATERIAL
- K964720 — VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
- K964771 — DE-TOX CONTROL 1 AND DE-TOX CONTROL 19
- K964864 — PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
- K964892 — FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
- K964914 — ALKALINE PHOSPHATASE
- K965047 — MINK LUNG CELL CULTURE
- K965159 — CETIBUTEN, 30MCG, SENSI-DISC
- K965166 — STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
- K965168 — STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)
- K965184 — PERFECTA PREGNANCY TEST
- K965227 — OSOM CLASSIC HCG-URINE TEST (115)
- K962468 — HEDROCEL ACETABULAR RESTRICTOR
- K962942 — TOTALCARE
- K963248 — FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
- K963671 — OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
- K964028 — SYS STIM 226
- K964137 — RTA RETINAL THICKNESS ANALYZER
- K964426 — SMARTOAE
- K964468 — IAMIN WET DRESSING (COPPER-SALINE)
- K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
- K964532 — MULTITAK SS SUTURE SYSTEM
- K964662 — FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
- K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
- K964851 — ENTRACARE THERMOMTER MODEL 1000
- K964933 — MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
- K962587 — CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM
- K963580 — IMAGYN FALLOPOSCOPY SYSTEM
- K963765 — STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
- K964371 — SHUNT TAP WITH ICP MONITORING ACCESS PORT
- K964386 — RADIONICS CONTOUR FLEX PLUS VALVE
- K964390 — CHASE VESSEL OCCLUDER
- K965060 — ULTRA-ETCH STAT
- K953938 — STERILEMAX
- K954674 — P1OP2B OR P1O92T
- K961521 — PATIENT EXAMINATION GLOVE
- K961975 — DISETRONIC D-MODEM
- K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
- K962813 — DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES
- K963764 — SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR
- K964041 — CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
- K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVER
- K964363 — BIPAP DUET SYSTEM
- K964367 — CES VASCULAR OCCLUSION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.